Cellectar Biosciences is a biopharmaceutical firm engaged in the research, development, and market introduction of therapeutic agents to combat cancer. The company's primary asset is CLR 131 (iopofosine I-131), a phospholipid drug conjugate (PDC), which is currently undergoing several clinical evaluations. It is in Phase 2 clinical trials for individuals with relapsed or refractory (r/r) Waldenstrom's macroglobulinemia and B-cell malignancies. Additionally, CLR 131 is being studied in Phase 2B for r/r multiple myeloma (MM) and in Phase I trials targeting a range of pediatric cancers, r/r head and neck cancers, and R/R MM. Furthermore, Cellectar is advancing CLR 1900, another PDC-based chemotherapeutic program, which is in preclinical stages with the aim of treating solid tumors. The firm also participates in collaborative PDC development initiatives with partners such as Avicenna Oncology GMBH for the CLR 2000 Series, Orano Med for the CLR 12120 Series, as well as IntoCell Inc. and LegoChemBio. Established in 2002, Cellectar Biosciences maintains its corporate headquarters in Florham Park, New Jersey.
Cellectar Biosciences to Present Compelling Efficacy Data from Phase 2 CLOVER WaM Subset Analysis of Iopofosine I 131 in Patients Refractory/Resistant to BTK Inhibitor Therapy at International Workshop for Waldenström Macroglobulinemia
Cellectar Biosciences will present Phase 2 CLOVER-WaM subset data at the International Workshop for Waldenström Macroglobulinemia (Oct 14-16, Palm Springs) showing iopofosine I 131 achieved a 79.2% major response rate and 87.5% overall response rate in WM patients refractory/resistant to BTK inhibitor therapy.
Duration of response exceeded 16 months in patients treated immediately post-BTKi after at least two prior lines of treatment — a heavily pretreated population with significant unmet need.
Management reaffirmed plans to dose the confirmatory Phase 3 trial in early 2027 and file for U.S. accelerated approval in 1H27, with a potential approval by end of 2027 given Breakthrough Therapy Designation.